This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.
Tetanus can be prevented with tetanus toxoid-containing vaccines (TT-containing vaccines, TTCVs), which are included globally in routine immunization programs for children, and in many countries at the time of prenatal care. China eliminated neonatal tetanus in 2012, but non-neonatal tetanus remains a serious public health problem. TT vaccine was first produced in 1924 and is used as a single antigen vaccine and combination vaccine component to prevent other vaccine-preventable diseases, including diphtheria, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b (Hib), and other vaccine-preventable diseases. Haemophilus influenzae type b (Hib).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
Center for Disease Control and Prevention, Qixingguan District, Bijie City
Bijie, Guizhou, China
Positive serum conversions of anti-tetanus toxoid IgG antibodies.
Time frame: 30 days after immunization
Incidence of adverse reactions (AR).
Time frame: 0-30 days after immunization
Geometric mean multiplicity of increase (GMI) of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Positivity rate of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Geometric mean concentration (GMC) of anti-tetanus toxoid IgG antibodies in serum.
Time frame: 30 days after immunization
Proportion of serum with anti-tetanus toxoid IgG antibody concentration ≥1.0 IU/ml
Time frame: 30 days after immunization
Incidence of AR.
Time frame: 30 minutes after immunization
Incidence of adverse events (AE).
Time frame: 0-30 days after immunization
Incidence of AE/AR.
Time frame: 0-7 days post-immunization
Incidence of serious adverse events (SAEs).
Time frame: 6 months post-immunization
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